Teirstein P S, Massullo V, Jani S, Tripuraneni P
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California 92037, USA.
Cardiovasc Radiat Med. 1999 Jan-Mar;1(1):3-7. doi: 10.1016/s1522-1865(98)00002-x.
Early studies indicate brachytherapy is a potential clinical treamtent for restenosis after coronary angioplasty procedures. The objective of this study was to evaluate the safety and efficacy of gamma radiation plus stenting in patients' previous restenosis.
In patients with previous coronary restenosis, balloon dilatation and/or coronary stenting was undertaken and then patients were randomly assigned to receive either Iridium-192 or placebo. Quantitative coronary angiographic, intravascular ultrasonographic, and clinical follow-up was obtained.
Of the 55 patients enrolled, 26 were treated with Iridium-192 and 29 were in the placebo group. Late luminal loss was significantly lower in the treated group compared to the placebo group (0.38 +/- 1.06 mm vs. 1.03 +/- 0.97 mm, p = 0.03). Restenosis (stenosis of > or = 50% at follow-up) was found in 17% of treated patients compared to 54% of placebo patients (p = 0.01). The need for target lesion revascularization was observed in 12% of patients in the treated group compared to 45% in the placebo group (p = 0.01).
In this initial trial, at 12 months follow-up, patients with previous restenosis were benefited by catheter-based gamma radiation therapy.
早期研究表明，近距离放射治疗是冠状动脉血管成形术后再狭窄的一种潜在临床治疗方法。本研究的目的是评估伽马射线照射联合支架置入术治疗既往再狭窄患者的安全性和有效性。
对既往有冠状动脉再狭窄的患者进行球囊扩张和/或冠状动脉支架置入，然后将患者随机分为接受铱-192治疗组或安慰剂组。进行定量冠状动脉造影、血管内超声检查及临床随访。
在纳入的55例患者中，26例接受铱-192治疗，29例为安慰剂组。治疗组的晚期管腔丢失显著低于安慰剂组（0.38±1.06mm对1.03±0.97mm，p=0.03）。治疗组17%的患者出现再狭窄（随访时狭窄≥50%），而安慰剂组为54%（p=0.01）。治疗组12%的患者需要进行靶病变血运重建，而安慰剂组为45%（p=0.01）。
在这项初步试验中，随访12个月时，既往有再狭窄的患者从基于导管的伽马射线放射治疗中获益。
